USPTO Seeks Public Feedback on The Experimental Use Exception to Patent Infringement

Attorney: Evan Smith
July 26, 2024

On June 27, 2024, the United States Patent and Trade Office (“USPTO”) published a request for comments (“RFC”) in the Federal Register inquiring about the current state of the experimental use defense to patent infringement and to determine the potential value of legislative action on the issue.  This RFC both supports the President’s 2021 Executive Order on Promoting Competition in the American Economy and furthers the United States Department of Agriculture and the USPTO’s joint commitment to evaluate “New proposals for incentivizing and protecting innovation in the seed and agricultural-related space, including the addition of research or breeders' exemptions for U.S. utility patents.”[1]<... Read more

PTAB Reverses Examiners on Unexpected Results

Attorney: Derek Lightner, Ph.D.
June 11, 2024

In Ex parte Freeman (USSN 16/270,259; TC 1600; Appeal 2023-000512, the underlying application being referred to herein as the “Freeman application”), a finding of obviousness and obviousness-type double patenting (ODP) was reversed on May 24, 2024. Freeman’s application was examined by Devang Thakor initially, but the case was taken over by another primary examiner, Nicole Babson, whose position was supported by Supervisor Patent Examiners, David Blanchard and Bethany Barham.<... Read more

When does a drug label induce infringement under 35 U.S.C. § 271(e)(2) of a patent not claiming an indication or method of use?

Attorney: Richard D. Kelly
January 23, 2024

In Corcept Therapeutics, Inc. v. Teva Pharmaceuticals U.S.A., Inc., C.A. 18-03632, December 29, 2023, the Chief Judge Bumb of the New Jersey District Court wrestled with the question of infringement under 35 U.S.C. 271(e)(2) where the drug labels of the generic and ethical drug were identical in the relevant parts.<... Read more

Federal Circuit Reiterates What Constitutes A Motivation to Combine, A Reasonable Expectation of Success, and Unexpected Results in New Chemical Compounds

Attorney: Sara Pistilli, PharmD.
August 30, 2023

In Sun Pharmaceutical Industries, Inc. v. Incyte Corporation, on August 22, 2023, the Federal Circuit affirmed a Final Written Decision of the Patent and Trial Appeal Board (the Board) of an inter partes review (IPR) asserting the claims of U.S. Patent No. 9,249,149 (the ’149 patent) as obvious under 35 U.S.C. § 103. The central argument was whether Sun’s “octo-deuterated” ruxolitinib analog (CTP-543) and “tetra-deuterated” ruxolitinib analogs, arising from claim 7 of the ’149 patent, were obvious in light of the prior art references presented by Incyte (Rodgers, Shilling, and the Concert Backgrounder).

Claim 7 recited:

The compound of claim 1, in which the compound is selected from the group consisting of:




or a pharmaceutically acceptable salt of any of the foregoing.<... Read more

Orphan Drug Exclusivity (ODE) – FDA Continues Its Attack

Attorney: Richard D. Kelly
June 27, 2023

Orphan drug exclusivity was created in 1983 to encourage pharmaceutical companies to develop drugs for diseases which affect less than 200,000 persons in the U.S. Jazz Pharmaceuticals developed Xwav^® to treat narcolepsy, a rare sleep disorder characterized by excessive daytime sleepiness and cataplexy, voluntary muscle weakness. Xywav^® received orphan drug exclusivity until July 2027 when it expires.  Xywav^® comprises the drug oxybate as mixed salts of calcium, magnesium, potassium, and sodium oxybate. The Orphan Drug Act 21 U.S.C. 360 cc (b) provides the exclusivity can be broken if: <... Read more